Novartis starts testing its swine flu vaccine

LONDON — Swiss drugmaker Novartis has begun injecting its swine flu vaccine into people in the company's first human tests, a spokesman said Wednesday.

The vaccine is being tested in a yearlong trial of 6,000 people of all ages in Britain, Germany and the United States, Novartis spokesman Eric Althoff told The Associated Press, adding that the vaccine will likely be on the market before the trial finishes.

A person in Britain became the first to get the swine flu vaccine about 10 days ago, he said.

Sanofi-Pasteur, which makes about 40 percent of the world's flu vaccines, expects to start testing its swine flu vaccine within days in the U.S. and Europe, according to spokesman Benoit Rungeard. Sanofi-Pasteur is a unit of Paris-based Sanofi-Aventis SA.

Since swine flu was declared to be a pandemic, or global outbreak, by the World Health Organization in June, pharmaceuticals have been racing to get their vaccines ready. Last month, Australian drugmaker CSL became the first vaccine maker to start testing its vaccine in humans in Australia.

"We initiated clinical trials about 10 days ago," Althoff said.

Half of Novartis' vaccines being tested are grown in chicken eggs, the traditional way of making flu vaccines, while the other half use a new cell-based technology.

The trial will test the vaccine's safety and whether one or two shots are necessary.

"Our assumption is that two doses will be required," Althoff said.

The vaccines being tested in Europe use an adjuvant, an ingredient used to boost the body's immune response. In the U.S., however, Novartis is only testing vaccines without adjuvants, Althoff said.

WHO recommends that countries use vaccines with adjuvants, to stretch the global supply of swine flu vaccine. However there are no licensed flu vaccines with adjuvants in the United States.

Once Novartis AG has preliminary data from the trial, they will submit that to drug regulators including the European Medicines Agency. European and U.S. regulators have a fast-track process for approving swine flu vaccine, to ensure it is available before the flu season starts in the fall, when swine flu is expected to surge.

The European Medicines Agency has previously said swine flu vaccines based on a pre-approved bird flu vaccine could be licensed within five days, even without extensive testing in humans.

Last month, WHO reported that the swine flu viruses being used to make the vaccine were not growing enough of a key ingredient, and said they were only producing half as much "yield" as regular flu viruses. The agency asked its laboratory network to produce a new set of viruses for vaccine makers to use.